One “fun” thing to talk about during the Regulatory lectures is the ongoing soap opera of what is happening to the 510(k) process.

One of the key events in the saga was a controversial report issued by the Institute of Medicine that basically said we should eliminate the 510K process. Here are two articles about that:

http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/Report-Brief.aspx

http://www.forbes.com/sites/larryhusten/2011/07/29/controversial-iom-report-highly-critical-of-510k-process/

You might find others.

What I would like to know for this discussion are several things, pick one or two to discuss:

1) Can someone come up with a brief bullet pointed history of this whole saga from the beginning? Hint: it started with an incident where a politician got the FDA to accept a 510K submission from a company when normally that 510K would have been denied.

2) What are some of the criticisms of the IOM’s report and its integrity?

3) What do critics of the IOM report suggest instead? What do you suggest and why?

4) Has there been any recent information on this saga?